XTalks

FEBRUARY 22, 2021

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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WCG Clinical

MAY 15, 2023

Study eDiaries are an example of a clinical research technology that can create additional burdens. As researchers, we must ask for patient feedback to better understand the ease of use of such patient technologies. Researchers must seek insights from the people who are the end users of these tools. It doesn’t.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

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Pharma Mirror

FEBRUARY 6, 2024

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments.

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pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Read on to learn why life science and clinical research professionals are choosing a career with Medpace.

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WCG Clinical

AUGUST 22, 2023

PRINCETON, NJ, August 22, 2023: WCG, the global leader in providing solutions that measurably improve the quality, efficiency, and safety of clinical research, today announces the WCG MAGI Clinical Research Conference, an educational mainstay for clinical trial professionals for more than 15 years, is going virtual for its fall 2023 event.

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XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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ACRP blog

MAY 1, 2023

As to whether DCTs save study teams time in conducting research, 66% of the respondents said they are “not sure” and 32% said “no way!” By partnering with these organizations, we learn their systems and technologies [to better understand their operations] within the clinical and non-clinical field.

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Find Me Cure

SEPTEMBER 2, 2020

As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. .

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pharmaphorum

SEPTEMBER 15, 2022

full traceability throughout the research process. In this blog, we provide an overview of the CDISC standards used in clinical research. SDTM was developed to organize data collected in clinical trials. SDTM metadata is submitted to regulators using the Define-XML data exchange standard. reduction of costs.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S. Partnerships and Global Site Development, and Darius D.

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ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S. Partnerships and Global Site Development, and Darius D.

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ACRP blog

SEPTEMBER 20, 2023

This is where I learned first-hand about some of the many challenges clinical researchers, especially at the site level, faced with patient recruitment and retention. Think about the changes or actions we can take today to either learn about, implement, or advocate for greater inclusion and diversity in clinical research.

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Dr Olena Karpenko.

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VirTrial

NOVEMBER 7, 2019

Clinical research is a critical component in determining the safety and effectiveness of medications, devices, and treatment regimens. Whether used for prevention, treatment, diagnosis or simply symptom relief, the pharmaceutical industry relies on clinical researchers to test and validate potential new remedies.

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pharmaphorum

NOVEMBER 15, 2021

New lay summary guidelines walk sponsors through their obligations under EU regulation No. The sooner patients are involved in developing and publishing lay summaries, which will soon be a legal requirement in the European Union, the better. Clinical trial sponsors work in a very regulated environment. Getting started.

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Pharma Mirror

MARCH 11, 2022

Casimir Further Differentiates Emmes’ Industry-Leading Rare Disease Research Capabilities Rockville, MD, March 10, 2022 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Casimir, a U.S.-based

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Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. French company Eurofins Scientific is currently developing and manufacturing both products.

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VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Watch the recording You can watch the recorded webinar here.

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XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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ACRP blog

JANUARY 30, 2024

“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S.

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ACRP blog

JULY 8, 2022

The JTF conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework (version 3.1). “The Investigational Product Design and Regulation. Data Management and Informatics. Ethical and Safety Considerations.

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Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The guidance mentions PBPK four times regarding renal function and DDIs.

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pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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ACRP blog

FEBRUARY 29, 2024

Education and training remain key elements in the development and professionalization of the clinical research workforce. 1,2} Two research-intensive academic medical centers (AMCs) are seeing benefits from competency-based job classifications. We needed a way to standardize our clinical research staff hiring process.

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pharmaphorum

DECEMBER 21, 2021

During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drug development to progress the number of treatments available to Rare Disease patients and to provide support to those individuals. Headway being made.

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XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their caregivers and the doctors that treat them.

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Pharmaceutical Technology

MAY 3, 2023

Janssen Biotech and the Cellular Biomedicine Group (CBMG) have entered a global collaboration and licence agreement for the development of next-generation chimeric antigen receptor (CAR) T-cell therapies to treat B-cell malignancies. The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL).

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Worldwide Clinical Trials

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Targeted Outreac h: Developing relationships with KOLs specializing in your indication can create a referral pipeline for suitable trial participants.

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Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Cameron Ross, SVP, Generative AI, Elsevier “AI has the potential to dramatically shorten one of the most costly areas of early drug development – small molecule discovery.

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Pharmaceutical Technology

FEBRUARY 24, 2023

She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. If you measure everything on faster, I’m not sure Europe will always come out ahead.” Outdated law Whatever the outcome, everyone involved agrees that the legislation needs a makeover. “We

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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